Question 1

What types of medical devices does DIO Corporation manufacture?

Accepted Answer

DIO Corporation specializes in dental implant components and related surgical tools. Their portfolio includes permanent and temporary preformed dental implant suprastructures, reusable and single-use dental fixtures like drill bits and abutment screws, endosteal dental implants (two-piece systems), guided surgery reference plates, and reusable surgical screwdrivers. These devices are designed to support dental restoration procedures, ensuring precision and compatibility with implant systems.

Question 2

Where is DIO Corporation based, and what markets do they serve?

Accepted Answer

DIO Corporation is headquartered in South Korea. Their devices are intended for use in both European and U.S. markets, as evidenced by their listings in the EUDAMED database (for EU regulatory compliance) and the FDA’s Unique Device Identifier (UDI) system (for U.S. traceability). This indicates their products meet the regulatory requirements of these regions for dental implants and surgical instruments.

Question 3

Which regulatory registries list DIO Corporation’s devices?

Accepted Answer

DIO Corporation’s devices are listed in two key regulatory databases: EUDAMED, the European Union’s medical device registry, and the FDA’s UDI system, which tracks medical devices in the United States. These listings help ensure transparency and traceability of their products in both markets, where their devices are authorised for use.

Question 4

How are DIO Corporation’s devices classified under EU regulations?

Accepted Answer

Under EU medical device regulations, DIO Corporation’s products fall into Class I, Class II, Class IIa, and Class IIb classifications. The classification depends on factors like the device’s risk level, intended use, and potential impact on patient safety—for example, implant systems and guided surgery tools are typically higher-risk (Class II or IIb) due to their invasive nature and critical role in dental procedures, while reusable fixtures like drill bits may fall into lower-risk categories like Class I or IIa.

Device	Model / Reference	Registries	Class	Status
DIO Implant System	IFI 4814PM	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	RCI 65014	FDA UDI	Class II	Unknown
DIO H-Scan Body	ITHSB 781	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSTI 4015N	FDA UDI	Class II	Active
DIOnavi. Tap Drill	GTD 4515	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 55205	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAC 4505	FDA UDI	Class II	Active
UF(II) Implant System	SSSA 65304	FDA UDI	Class II	Unknown
FTN Fixture Mount	EMT 50210[T]	FDA UDI	Class I	Active
UF(II) Implant System	UF(II) 4010SF	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 65305N(II)	FDA UDI	Class II	Unknown
UF(II) Implant System	UF(II) 3811SF	FDA UDI	Class II	Active
UF(II) Pre-Milled Bar	CBSS 02[H]	FDA UDI	Class I	Active
DIOnavi. Drill Tube	UDT 40	FDA UDI	Class I	Active
UF(II) Eco Base Abutment	USBA 6504H	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	APN 50613N	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DAUR 2555H	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSTI 5510N	FDA UDI	Class II	Active
UF(II) Wide	UF(II) 6507SF	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 45507	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 4008S	FDA UDI	Class II	Unknown
SM-Extra Wide Implant System	MX 5906	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	SSN 2003	FDA UDI	Class II	Unknown
DIO Water Membrane Lifter Body	WML 6627-1	FDA UDI	Class I	Active
DIOnavi. Initial Drill	ISD 2017N	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 552015BH	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DUR 2555N	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AAN 35215	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	ABI 48350	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 6547	FDA UDI	Class II	Unknown
UF(II) Eco Digital Coping Screw	USCSC 1405H	FDA UDI	Class I	Active
UF(II) Wide	UF(II) 6510SF	FDA UDI	Class II	Unknown
Dio Protem Implant System	MFB 25410	FDA UDI	Class II	Active
DIOnavi. Straight Drill	USD 2705	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AHN 35408	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	AAT 50425	FDA UDI	Class II	Active
UF(II) Implant System	UF(II) 3810SF	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMN 40540N	FDA UDI	Class II	Unknown
Hybrid Link	UNHL 40401H	FDA UDI	Class II	Active
DIO H-Scan Body	ITHSB 642	FDA UDI	Class I	Active
DIOnavi-Denture	3DDEN-500	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 55407N(II)	FDA UDI	Class II	Active
UF(II) Eco Transfer Impression Coping	USTI 5510N	FDA UDI	Class I	Active
DIOnavi. Guide	GUIDE02 14(a,b)	FDA UDI	Class I	Active
DIO Removing Driver	HR 12L	FDA UDI	Class I	Active
UF(II) Implant System	UF(II) 5016SF	FDA UDI	Class II	Active
DIO Steady External Implant System	ESF 5010R	FDA UDI	Class II	Unknown
UF(II) Narrow Pick-up Impression Coping	UNSPI 4014N	FDA UDI	Class I	Active
UF(II) Internal Pre-Milled Bar	CBSI 01[H]	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 75407N(II)	FDA UDI	Class II	Active

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